Reserpine for the Treatment of Cocaine Dependence - 1

Phase 2

Completed

• Conditions: Cocaine-Related Disorders; Substance-Related Disorders

• Registration Number: NCT00033033
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

Detailed Description

To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2002-04-05
• Study First Submitted QC: 2002-04-05
• Study First Posted: 2002-04-08
• Study Completion: 2003-05
• Status Verified: 2008-08
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method

Exclusion Criteria

Additional criteria available during screening at the site.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cocaine use
Addiction severity
Cocaine withdrawal
Adverse events
Clinical improvement

Trial Locations

Locations (3)

Cincinnati VA Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Dayton VA Medical Center; 🇺🇸 Dayton, Ohio, United States

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States